Posted
by
timothy
on Thursday July 19, 2012 @04:59PM
from the keep-'em-zipped dept.

dstates writes "An industry has grown up around patents guaranteeing exclusive access to testing of mutations in specific genes, but recently the Supreme Court rejected a biotechnology patent saying laws of nature cannot be patented, and threw the issue of patents on genes back to the lower courts. The Court of Appeals is now preparing to hear arguments on whether genes can be patented. The results will have major implications. On the one hand, restricting access to whole regions of the human genome will stifle scientific progress. On the other, companies like Myriad Genetics and Optimal Medicine use the patents to protect years of work invested in research, but this also means preventing other companies from offering diagnostics based on competing faster and lower cost technologies to analyze mutations in these genes."

It only takes a single reasonably reputable court (a Federal Circuit Court of Appeals for example) to say yes and another to say no for the issue to require escalation to the Supreme court. Even if it was 10 yes and only 1 no, that still means there is ambiguity about the national stance on the issue and the SCOTUS should hear the case. It doesn't mean that all the judges in all the cases were saying the wrong thing until SCOTUS, it just means one judge said the wrong thing early enough in the issue's existence or with enough weight to introduce ambiguity on the legality nationwide.

The Bloomberg article cited in the summary is rather one-sided in its treatment of the subject. While speaking extensively to the potential damage that invalidation of human gene patents (at least for 'isolated' DNA) may do to the industry, it does not mention the potential benefits, which include opening space for start-ups and other small business to perform research and create products which they currently cannot due to patents on human genes. Invalidation of human gene patents would, of course, not be terribly beneficial to the current big players who now tend to simply cross-license their patents and thus block new competition.

Also, the article fails to explore properly WHY there is an argument over whether human genes should be patentable subject matter. The Supreme Court has held for many decades that products of nature are not patentable subject matter--so you cannot find a new mineral in a mine and get a patent on it. The Federal Circuit (the appeals court which handles patent appeals matters) has consistently held that isolated human genes, even when the sequence is exactly that of a normal human gene's coding region, are products of human ingenuity and not products of nature as the genes have been isolated from the gene's normal context--that of the chromosome. Many research scientists find this a specious argument, as isolation of a gene is a routine practice in the field. A recent Supreme Court holding (Mayo v. Prometheus) suggested that, for some patent claims at least, a law of nature or product of nature is not transformed into a product of man by some routine or common activity. So this argument will boil down to whether isolation of a human gene and placement of that gene into a plasmid (for copying, manipulation, expression, etc.) is enough to convert a product of nature into something made by the hand of man.

Monsanto is doing this with crops already. If their gene contaminates your crop through natural means (wind pollination, direct seed drift, bees etc. You are on the hook. They can take control of the entire crop including the uncontaminated parts of your crop and the vigorously litigate these scenarios.